Severe to profound hearing loss is associated with measurable deficits in health-related quality of life (HRQoL), reflecting its concomitant effects o oral language, social and emotional functioning, and academic performance. However, studies of cochlear implantation (CI) have focused on clinical measures of efficacy related to language and communication (e.g., auditory, speech, language skills), and have not captured the implant's effects on daily functioning. HRQoL measures provide a unique assessment of the effects of a CI on a broad range of outcomes, from the child and family's perspective. These patient-reported outcomes (PROs) are now required by the FDA to measure clinically meaningful effects (FDA Guidance, 2009). To date, there are no CI-specific HRQoL measures for young children and their parents (Morettin et al., 2013). The goal of this study is to develop the first HRQoL instruments for children with CIs, ages 6 to 12, and their parents. The proposed instruments will use the FDA measurement process. Phase I includes a systematic literature review and focus groups with key stakeholders (e.g., implant surgeons, audiologists) to identify relevant content and create a testable, conceptual framework. We will also conduct open-ended interviews with children with CIs and their parents (n = 24 dyads) to understand the impacts of childhood deafness on daily functioning. In Phase II, data from the interviews will be used to create provisional questionnaires that will be revised and refined through cognitive interviews with 24 children and their parents recruited from two cochlear implant centers (The University of Miami, Children's Hospital of Philadelphia). To increase generalizability, the instruments will be created using families from varied ethnic/racial backgrounds and oral/signing children with CIs. The measures will be developed in both English and Spanish, utilizing a culturally sensitive approach to ensure the measures are valid for families who do not use spoken English as a first language. In Phase III, the final instruments will be used to collect initial reliability and validty data in a demographically diverse sample (n = 80 dyads of children with CIs and their parents). Convergent validity will be tested with the child and parent versions of the KINDL (a generic HRQoL measure used in previous research). It is hypothesized that both CI- specific measures will demonstrate strong reliability and validity. These data will be used to submit a follow-up proposal to fund a multi-site psychometric validation, including tests of reliability (i.e., internl consistency, test- retest), predictive and convergent validity, and responsivity to change. Development of HRQoL measures for children with CIs and their parents will enable clinicians to: 1) identify specific areas of patient and family need; 2) measure the effects of cochlear implantation on patient/family functioning; 3) compare language performance in children with unilateral vs. bilateral CIs; 4) assess the efficacy of interventions (e.g., AV therapy, social skils) to improve implant use; and 5) provide patient-centered clinical information to improve care.